FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
K Number: K790262
·
Decision Feb 13, 1979
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
84
Applicant Total
308
Review Days
7
Basic Information
- Device Name
- UNIVERSAL EXTERNAL FIXATION ASSEMBLY
- K Number
- K790262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- ZIMMER, INC.
- Date Received
- February 6, 1979
- Decision Date
- February 13, 1979
- Product Code
- JEC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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